EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled— 510(k) K202066

Clearance details

Applicant

ABBOTT MEDICAL

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2020-07-27

Decision date

2020-11-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Paul, MN, US

• K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
• K262005 — Affera Integrated Mapping System2026-08-21
• K253576 — CorVista System® with PCWP Add-On2026-07-26
• K262006 — EnSite X EP System2026-07-15
• K252978 — ScioCardio ECG Analysis Platform2026-07-09

• K261631 — Amplatzer TorqVue Exchange System2026-06-17
• K253459 — OPTIS Mobile Next Imaging System (1014932) +2 more2026-04-24
• K260212 — EnSite X EP System2026-04-20
• K253907 — Disposable Radiofrequency Cannula2026-04-16
• K260499 — Amplatzer Trevisio Intravascular Delivery System +1 more2026-03-13

Death

10

Injury

225

Malfunction

2,123

Other

2

Total

2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →